Attachment_3_FDA_Form_3398.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

SPECIAL GOVERNMENT EMPLOYEE'S COMMITMENT TO PROTECT

NON-PUBLIC INFORMATION (NPI) AGREEMENT

Whereas access to non-public information (NPI) from the files of the Food and Drug Administration (FDA) is required in the performance of my official duties as a Special Government Employee, I

, hereby agree as part of such employment, that I shall not further release, publish or disclose such information and I shall protect such information entrusted to me in accordance with the provisions of 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 18 U.S.C. § 1905, as well as other applicable statutory and regulatory provisions.

FORM FDA 3398a (7/13) PSC Publishing Services (301) 443-6740

Further, I agree to:

1. Review with the FDA Field/Headquarters Physical Security Coordinator, if applicable, the security measures I will employ in protecting NPI entrusted to me.

2. Indicate my receipt for NPI information below, as well as retain all U.S. Registered Mail return receipt used to transmit NPI.

3. Store NPI and any pertinent notes in containers provided by FDA, or in accordance with written instructions provided by FDA.

4. Ensure all containers storing NPI are locked when not under my personal supervision and maintain personal custody of keys and combinations to such containers.

5. Grant access to NPI only to known employees of the FDA or to other persons designated in writing by the FDA.

6. Return all NPI and any pertinent notes to FDA (1) upon completion of my "reviews", (2) when a need for the information no longer exists, (3) when terminated by FDA as a Special Government Employee,

(4) or at any time upon FDA's request.

7. Make arrangements to return all storage containers provided by FDA upon the termination of my status as a Special Government Employee.

8. Promptly report in writing to the FDA Physical Security Staff (HFA-204), 10903 New Hampshire Avenue, Building 2, Room 0028, Silver Spring, MD 20993 (Phone 301-796-2408, Fax 301-796-9760), all incidents in which unauthorized persons may have gained access to any NPI entrusted to me.

I understand the provisions of 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 18 U.S.C. § 1905 and that I am subject to criminal penalties prescribed by law for any violation thereof.

Receipt of the following NPI is hereby acknowledged:

Signature: Date:

Type or Print Name:

Witnessed by: Date:

Type or Print Name:

EF

Allison.Mlawsky Typewritten Text

Allison.Mlawsky Typewritten Text

Allison.Mlawsky Typewritten Text

Allison.Mlawsky Typewritten Text

Allison.Mlawsky Typewritten Text Attachment 3

Allison.Mlawsky Typewritten Text

Allison.Mlawsky Typewritten Text

Allison.Mlawsky Typewritten Text

Allison.Mlawsky Typewritten Text

Allison.Mlawsky Typewritten Text

FORM FDA 3398a PSC Publishing Services

HHS/FDA

Special Government Employee's Commitment to Protect Non-Public Information (NPI) Agreement

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration SPECIAL GOVERNMENT EMPLOYEE'S COMMITMENT TO PROTECT NON-PUBLIC INFORMATION (NPI) AGREEMENT SPECIAL GOVERNMENT EMPLOYEE'S COMMITMENT TO PROTECT NON PUBLIC INFORMATION (N P I) AGREEMENT.

Whereas access to non-public information (NPI) from the files of the Food and Drug Administration (FDA) is required in the performance of my official duties as a Special Government Employee, I Whereas access to non public information (N P I) from the files of the Food and Drug Administration (FDA) is required in the performance of my official duties as a Special Government Employee, I , hereby agree as part of such employment, that I shall not further release, publish or disclose such information and I shall protect such information entrusted to me in accordance with the provisions of 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 18 U.S.C. § 1905, as well as other applicable statutory and regulatory provisions.

further release, publish or disclose such information and I shall protect such information entrusted to me in accordance with the provisions of 21 U. S. C. section 3 31 (j), 21 U. S. C. section 3 60 (j), 18 U. S. C. section 19 0 5, as well as other applicable statutory and regulatory provisions.

FORM FDA 3398a (7/13) FORM FDA 33 98 a (July 2013).

PSC Publishing Services (301) 443-6740 P S C Publishing Services (3 0 1) 4 4 3 - 67 40.

Further, I agree to:

1. Review with the FDA Field/Headquarters Physical Security Coordinator, if applicable, the security measures I will employ in protecting NPI entrusted to me.

1. Review with the FDA Field/Headquarters Physical Security Coordinator, if applicable, the security measures I will employ in protecting N P I entrusted to me.

2. Indicate my receipt for NPI information below, as well as retain all U.S. Registered Mail return receipt used to transmit NPI.

2. Indicate my receipt for N P I information below, as well as retain all U. S. Registered Mail return receipt used to transmit N P I.

3. Store NPI and any pertinent notes in containers provided by FDA, or in accordance with written instructions provided by FDA.

3. Store N P I and any pertinent notes in containers provided by FDA, or in accordance with written instructions provided by FDA.

4. Ensure all containers storing NPI are locked when not under my personal supervision and maintain personal custody of keys and combinations to such containers.

4. Ensure all containers storing N P I are locked when not under my personal supervision and maintain personal custody of keys and combinations to such containers.

5. Grant access to NPI only to known employees of the FDA or to other persons designated in writing by the FDA.

5. Grant access to N P I only to known employees of the FDA or to other persons designated in writing by the FDA.

6. Return all NPI and any pertinent notes to FDA (1) upon completion of my "reviews", (2) when a need for the information no longer exists, (3) when terminated by FDA as a Special Government Employee, (4) or at any time upon FDA's request.

6. Return all N P I and any pertinent notes to FDA (1) upon completion of my "reviews", (2) when a need for the information no longer exists, (3) when terminated by FDA as a Special Government Employee, (4) or at any time upon FDA's request.

7. Make arrangements to return all storage containers provided by FDA upon the termination of my status as a Special Government Employee.

8. Promptly report in writing to the FDA Physical Security Staff (HFA-204), 10903 New Hampshire Avenue, Building 2, Room 0028, Silver Spring, MD 20993 (Phone 301-796-2408, Fax 301-796-9760), all incidents in which unauthorized persons may have gained access to any NPI entrusted to me.

8. Promptly report in writing to the FDA Physical Security Staff (H F A - 2 0 4), 1 0 9 0 3 New Hampshire Avenue, Building 2, Room 0 0 2 8, Silver Spring, Maryland 2 0 9 9 3 (Phone 3 0 1 7 96 24 08, Fax 3 0 1 7 96 97 60), all incidents in which unauthorized persons may have gained access to any N P I entrusted to me.

I understand the provisions of 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 18 U.S.C. § 1905 and that I am subject to criminal penalties prescribed by law for any violation thereof.

I understand the provisions of 21 U. S. C. section 3 31 (j), 21 U .S. C. section 3 60 (j), 18 U. S. C. section 19 0 5 and that I am subject to criminal penalties prescribed by law for any violation thereof.

Receipt of the following NPI is hereby acknowledged:

Receipt of the following N P I is hereby acknowledged:

Signature:

Date:

Type or Print Name:

Witnessed by:

Date:

Type or Print Name:

EF

E F.